scholarly journals Development of a new patient-reported outcome (PRO) measure on the Impact of Nighttime Urination (INTU) in patients with nocturia-Psychometric validation

2018 ◽  
Vol 37 (5) ◽  
pp. 1678-1685 ◽  
Author(s):  
Jason B. Bennett ◽  
Kristin Khalaf Gillard ◽  
Benjamin Banderas ◽  
Steven Abrams ◽  
Linda Cheng ◽  
...  
Keyword(s):  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Patient Reported ◽  
The Impact

scholarly journals Development and validation of Gaucher disease type 1 (GD1)-specific patient-reported outcome measures (PROMs) for clinical monitoring and for clinical trials

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Deborah Elstein ◽  
Nadia Belmatoug ◽  
Patrick Deegan ◽  
Özlem Göker-Alpan ◽  
Derralynn A. Hughes ◽  
...  
Keyword(s):  
Gaucher Disease ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Specific Patient ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Development And Validation ◽  
The Impact

Abstract Background Disease-specific patient-reported outcome measures (PROMs) are fundamental to understanding the impact on, and expectations of, patients with genetic disorders, and can facilitate constructive and educated conversations about treatments and outcomes. However, generic PROMs may fail to capture disease-specific concerns. Here we report the development and validation of a Gaucher disease (GD)-specific PROM for patients with type 1 Gaucher disease (GD1) a lysosomal storage disorder characterized by hepatosplenomegaly, thrombocytopenia, anemia, bruising, bone disease, and fatigue. Results and discussion The questionnaire was initially developed with input from 85 patients or parents of patients with GD1 or GD3 in Israel. Owing to few participating patients with GD3, content validity was assessed for patients with GD1 only. Content validity of the revised questionnaire was assessed in 33 patients in the US, France, and Israel according to US Food and Drug Administration standards, with input from a panel of six GD experts and one patient advocate representative. Concept elicitation interviews explored patient experience of symptoms and treatments, and a cognitive debriefing exercise explored patients’ understanding and relevance of instructions, items, response scales, and recall period. Two versions of the questionnaire were subsequently developed: a 24-item version for routine monitoring in clinical practice (rmGD1-PROM), and a 17-item version for use in clinical trials (ctGD1-PROM). Psychometric validation of the ctGD1-PROM was assessed in 46 adult patients with GD1 and re-administered two weeks later to examine test–retest reliability. Findings from the psychometric validation study revealed excellent internal consistency and strong evidence of convergent validity of the ctGD1-PROM based on correlations with the 36-item Short Form Health Survey. Most items were found to show moderate, good, or excellent test–retest reliability. Conclusions Development of the ctGD1-PROM represents an important step forward for researchers measuring the impact of GD and its respective treatment.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals Development of a patient-reported outcome measure for neck pain in military aircrew: qualitative interviews to inform design and content

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039488
Author(s):  
Anna Dowling ◽  
Ellen Slungaard ◽  
Nicola R Heneghan
Keyword(s):  
Neck Pain ◽  
Outcome Measure ◽  
Physical Symptoms ◽  
Patient Reported Outcome ◽  
Direct Access ◽  
Specific Patient ◽  
Concept Elicitation ◽  
Patient Reported Outcome Measure ◽  
Patient Reported ◽  
The Impact

IntroductionThe prevalence of flight-related neck pain is 70% in UK fast jet pilots; much higher than the general population. The Aircrew Conditioning Programme and direct access physiotherapy exist to minimise the impact on military capability, but a population specific patient-reported outcome measure (PROM) is required to investigate the effectiveness of these. We aimed to explore the experiences of flight-related neck pain to inform the content validity and development of a population specific PROM.MethodsQualitative semistructured interviews combining phenomenological and grounded theory methods, reported using Consolidated criteria for Reporting Qualitative research guidelines. A purposive sample of 10 fast jet pilots with neck pain was recruited. Concept elicitation interviews were audio recorded, transcribed verbatim along with field notes. Data analysis involved subject and methodological expertise used a concept elicitation approach.ResultsParticipants included 10 male fast jet pilots, age 34.7 years. Identified themes included: (1) physical symptoms associated with flying activities; (2) occupational effects revealed modifications of flying, or ‘suboptimal’ performance owing to neck pain; (3) psychological effects revealed feelings or worry and (4) social and activity effects showed impact on out of work time.ConclusionPopulation-specific occupational, psychological and social factors should be considered alongside physical symptoms when managing neck pain in military aircrew. Findings support the development of a PROM specifically designed for military aircrew with neck pain.

Correlation between nasal mucosal temperature change and the perception of nasal patency: a literature review

2021 ◽  
Vol 135 (2) ◽  
pp. 104-109
Author(s):  
R Tjahjono ◽  
N Singh
Keyword(s):  
Temperature Change ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Subjective Perception ◽  
Nasal Patency ◽  
Patient Reported Outcome Measure ◽  
Physical Measurements ◽  
Pubmed Database ◽  
Patient Reported ◽  
The Impact

AbstractBackgroundThe mechanism of nasal airflow sensation is poorly understood. This study aimed to examine the role of nasal mucosal temperature change in the subjective perception of nasal patency and the methods by which it can be quantified.MethodMedline and PubMed database searches were performed to retrieve literature relevant to the topic.ResultsThe primary mechanism producing the sensation of nasal patency is thought to be the activation of transient receptor potential melastatin family member 8 (‘TRPM8’), a thermoreceptor that is activated by nasal mucosal cooling. Computational fluid dynamics studies have demonstrated that increased airflow and heat flux are correlated with better patient-reported outcome measure scores. Similarly, physical measurements of the nasal cavity using temperature probes have shown a correlation between lower nasal mucosal temperatures and better patient-reported outcome measure scores.ConclusionNasal mucosal temperature change may be correlated with the perception of improved nasal patency. Future research should quantify the impact of mucosal cooling on the perception of nasal airway obstruction.

Nonunion Rates After Anterior Cervical Discectomy and Fusion: Comparison of Polyetheretherketone vs Structural Allograft Implants

Neurosurgery ◽  
2021 ◽  
Author(s):  
Won Hyung A Ryu ◽  
Dominick Richards ◽  
Mena G Kerolus ◽  
Adewale A Bakare ◽  
Ryan Khanna ◽  
...  
Keyword(s):  
Smoking Status ◽  
Posterior Instrumentation ◽  
Patient Reported Outcome ◽  
Anterior Cervical Discectomy ◽  
Successful Outcome ◽  
Cervical Discectomy ◽  
Structural Allograft ◽  
Modifiable Factors ◽  
Patient Reported ◽  
The Impact

Abstract BACKGROUND Although advances in implant materials, such as polyetheretherketone (PEEK), have been developed aimed to improve outcome after anterior cervical discectomy and fusion (ACDF), it is essential to confirm whether these changes translate into clinically important sustained benefits. OBJECTIVE To compare the radiographic and clinical outcomes of patients undergoing up to 3-level ACDF with PEEK vs structural allograft implants. METHODS In this cohort study, radiographic and symptomatic nonunion rates were compared in consecutive patients who underwent 1 to 3 level ACDF with allograft or PEEK implant. Prospectively collected clinical data and patient-reported outcome (PRO) scores were compared between the allograft and PEEK groups. Regression analysis was performed to determine the predictors of nonunion. RESULTS In total, 194 of 404 patients met the inclusion criteria (79% allograft vs 21% PEEK). Preoperative demographic variables were comparable between the 2 groups except for age. The rate of radiographic nonunion was higher with PEEK implants (39% vs 27%, P = .0035). However, a higher proportion of nonunion in the allograft cohort required posterior instrumentation (14% vs 3%, P = .039). Patients with multilevel procedures and PEEK implants had up to 5.8 times the risk of radiographic nonunion, whereas younger patients, active smokers, and multilevel procedures were at higher risk of symptomatic nonunion. CONCLUSION Along with implant material, factors such as younger age, active smoking status, and the number of operated levels were independent predictors of fusion failure. Given the impact of nonunion on PRO, perioperative optimization of modifiable factors and surgical planning are essential to ensure a successful outcome.

Psychometric validation of the dysmenorrhea daily diary (DysDD): a patient-reported outcome for dysmenorrhea

2017 ◽  
Vol 26 (8) ◽  
pp. 2041-2055 ◽  
Author(s):  
Allison M. Nguyen ◽  
Rob Arbuckle ◽  
Tjeerd Korver ◽  
Fang Chen ◽  
Beverley Taylor ◽  
...  
Keyword(s):  
Daily Diary ◽  
Patient Reported Outcome ◽  
Psychometric Validation ◽  
Patient Reported
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